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Primary analysis results from JULIET trial
Primary analysis results from JULIET trial.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 9275Y Oxford Biomedica PLC 11 December 2017 \n\n \n \n \n \n \n \nOxford BioMedica notes the primary analysis results from the pivotal JULIET trial demonstrating that Kymriah™ (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer\n \nOxford, UK - 11 December 2017: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Group\") (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis on the updated results from the JULIET clinical trial demonstrating sustained responses with Kymriah™ (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.\n \nThe data from this pivotal trial, led by researchers from the University of Pennsylvania (Penn), show an overall response rate (ORR) of 53% (95% confidence interval [CI], 42% - 64%; p<0.0001), with 40% achieving a complete response (CR) and 14% achieving a partial response (PR) among 81 infused patients with three or more months of follow-up or earlier discontinuation. At six months from infusion, the ORR was 37% with a CR rate of 30%. The median duration of response was not reached.\n \nResults from this study of Kymriah, the first-ever FDA-approved chimeric antigen receptor T cell (CAR-T) therapy, were included in the US and EU regulatory filings for Kymriah in r/r DLBCL and will be presented in an oral presentation at the 59th American Society of Hematology (ASH) annual meeting (Abstract #577; Monday, December 11, 7:00 AM EST)1.\n \nResults of a cost-effectiveness analysis of Kymriah for the treatment of r/r B-cell ALL in the US will be presented in an oral presentation at the meeting (Abstract #609; Monday, December 11, 7:30 AM EST). The analysis showed that, based on the current US list price of $475,000, Kymriah is cost-effective compared to standard of care2.\n \nIn addition, results of another analysis to determine the potential societal value of Kymriah to patients with r/r ALL in the United Kingdom were presented in a poster presentation at the meeting (Abstract #1330; Saturday, December 9...